Systems Designer / Analyst II

Spectraforce Technologies; Raleigh (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Spectraforce Technologies is seeking a Systems Designer / Analyst II to support data-driven clinical trials. Based in Lake Forest, IL, you will contribute to the design and delivery of clinical systems (EDC, IRT, ePRO) while ensuring adherence to standards and regulatory requirements.

You will mentor team members, lead cross-functional initiatives, and ensure timely delivery of system designs aligned with CDASH and SDTM. Strong communication and 7+ years in EDC are preferred.

Qualifications

• Bachelor's degree in business, MIS, computer science, life sciences or equivalent; Masters preferred.
• 7+ years hands-on technical study build in EDC; Medidata RAVE experience required; Veeva EDC is a plus.
• In-depth knowledge of clinical trial processes, CDASH, and SDTM.
• Proven ability to coach/mentor in a matrix environment and influence others.

Responsibilities

• Develops and ensures adherence to data standards; ensures designs meet protocol requirements.
• Establishes methodologies for designing and developing clinical trial systems and benchmarks against industry standards.
• Ensures team consistency across TA and program levels.
• Delivers on-time design and delivery of new clinical systems and integrations; tracks progress and mitigates risks.
• Collaborates with CDO and cross-functional members to achieve program objectives.
• Keeps up-to-date with GCPs, ICH guidelines, AbbVie SOPs and regulatory requirements.
• Coaches and mentors team members and leads innovations and process improvements.

Skills

EDC hands-on

Medidata RAVE

CDASH

SDTM

Veeva EDC

Regulatory knowledge

Communication

Mentoring

Education

Bachelor's degree; Masters preferred in related fields

Job description

Position Title: Systems Designer / Analyst II

Work Location: Lake Forest, IL

Assignment Duration: 12 Months

Purpose

Data Science is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Clinical Data Strategy Organization.

Responsibilities

• Actively participates in the development of common data standards and ensures systems designs comply with the standards, as well as with associated protocol requirements. Ensures that the design team utilizes standards
• Establishes and maintains methodology used by the team to design and develop clinical trial systems, benchmarking against industry standards. Ensures that systems are specified to optimize functionality, end user experience, and data flow. Ensures that the design team meets these expectations
• Ensures that TA- and program-level consistency is achieved by the design team
• Accountable for the on-time design and delivery of new clinical systems, integration between systems, as well as any required changes to clinical systems (e.g., EDC, IRT, ePRO). Utilizes project management tools to track study progress and plan work. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions
• Interacts with and influences CDO and cross-functional team members to achieve program and study objectives. Ensures that assigned work product is synchronized with upstream and downstream dependencies
• Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development
• Responsible for coaching and mentoring members of the team, as well as contributing to their skill development
• Leads CDO and cross-functional innovation and process improvement initiatives

Qualifications

• Bachelor's degree in business, management information systems, computer science, life sciences or equivalent. Masters preferred.
• Must have 7+ years of hands-on technical Study build in EDC. Experience with technical study build in Medidata RAVE is required. Veeva EDC technical study build experience is a plus.
• In-depth knowledge of clinical trial processes.
• In-depth knowledge of CDASH (Required) and SDTM.
• Demonstrated performance as a key contributor to initiatives and advancement of the organization.
• Demonstrated ability to influence others without direct authority. Demonstrated ability to successfully coach / mentor in a matrixed environment. Demonstrated effective communication skills and analytical skills.